Once a safety signal is identified, it undergoes a rigorous evaluation process:
Initial Assessment: The preliminary data is reviewed to determine the validity and relevance of the signal. Data Collection: Additional data is collected from various sources to support or refute the signal. Causality Assessment: The relationship between the exposure and the adverse effect is analyzed. Risk Management: If the signal is confirmed, risk management strategies, such as label changes, restricted use, or market withdrawal, are implemented.
